BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXT DETACHABLE COIL, MULTI-DIAMETER.

    MDR report key: 607590 · Received May 26, 2005

    Report

    Report Number
    2029214-2005-00034
    Event Type
    Injury
    Date Received
    May 26, 2005
    Date of Event
    March 12, 2005
    Report Date
    May 26, 2005
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN COILING SAH ICA PH-COMM 7MM ANEURYSM WITH ECHELON 14 MICRO CATHETER AND DEPLOYED ATLAS 7MM COILD WITHOUT INCIDENT. PHYSICIAN CHOSE N-6-20-T10-MD AS SECOND COIL AND PLACED PARTIALLY INTO ANEURYSM AND NEEDED TO REPOSITION. WHEN PHYSICIAN REPOSITIONED COIL, THE COIL BROKE, LEFT IN THE ICA AND THE CASE WAS ENDED. DURING EVENING, PATIENT CONDITION WORSENED. PHYSICIAN PERFORMED ANGIOGRAPHY AND DETERMINED COIL LOOP HAD MIGRATED INTO THE MCA. NEXT DAY, PHYSICIAN UTILIZED MICROVENA SNARE AND WAS ABLE TO SNAG AND REMOVE COIL. NO PATIENT SEQUELAE AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXT DETACHABLE COIL, MULTI-DIAMETER. ELECTROLYTICALLY DETACHABLE COIL HCG MICRO THERAPEUTICS, INC. N-6-20-T10-MD 854510

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening